Field of the Invention
The present invention relates to the field of intravenous catheters and more particularly relates to a protector which protects the venepuncture site, catheter, attached intravenous tubing and injection cap.
Intravenous catheters are extensively used for hydration and the administration of medications, feeding and for blood transfusions. Representative intravenous fluids include medications of various types, blood, plasma, dextrose, and saline solutions. IV infusions are generally carried out with a container of IV fluid suspended above the patient and the fluid is delivered to the patient at an administration needle or catheter through a drip chamber and flexible tubing connected to the container at a piercing spike. The infusion flow rate is regulated by use of an external pinch valve, in-line controller or IV pump. Medication may also be administered by direct injection.
Initially when infusions are carried out, the tubing and catheter are purged of air by initiating a flow of fluid through the tubing. The catheter is then inserted into a vein at a suitable location such as in the wrist area and the infusion is initiated. Preferably when the venepuncture site (sometimes venipuncture) is located at or adjacent a joint, the area should be properly stabilized. The appropriate flow rate is established by timing the rate of flow at the drip chamber.
When intravenous fluid is to be administered to a patient over an extended period of time, it is general practice to insert the catheter into the venepuncture site and retain the catheter in position by an adhesive membrane such as that commonly known as Opsite. This simple arrangement helps to protect the venepuncture site and stabilization of the catheter, however, this procedure does not protect the exposed portion of the catheter and tubing. Accordingly, it is easy for a patient to inadvertently strike a portion of the bed or engage the bed clothes with the catheter or tubing which will cause movement of the catheter at the venepuncture site. This occurrence may cause pain to the patient and more importantly may result in deterioration of the venepuncture site so that the readministration of the IV will be required which involves substantial time on the part of the medical attendant. The medical regulations of most states require that IV's be administered only by physicians or registered nurses so the professional medical time involved in repeating these procedures as well as additional supplies requested for a re-start and represent added expense to the hospital and patient. Re-starts also take the physician or nurse away from other important duties. Trauma at the venepuncture site increases the chances for infection and increases the risk of phlebitis.
The problems due to an exposed catheter are particularly acute today since conventional medical practice often requires leaving the catheter in place after completion of the intravenous infusion. The exposed end of the catheter is capped with an injection cap (sometimes termed a Heparin Lock) to provide convenient access for the administration of medications such as emergency drugs, antibiotics, diuretics and cortico steroids.
In addition to the problem of inadvertent contact of the IV catheter and associated tubing, some patients present particular problems. Pediatric patients may be especially active and curious and may through such activity dislodge the catheter. Similarly, some patients due to medications, emotional, physical or psychological condition may intentionally interfere with medical equipment and procedures including the catheter.
Because of the concern of medical personnel relative to protection of the vena site, medical personnel have often resorted to make-shift devices to enclose the site. One common method involves the use of a portion of an expanded foam or acrylic drinking cup which has been longitudinally cut in half. Generally the cup half is inverted and placed over the area and taped in place. Obviously there are substantial disadvantages with make-shift devices of this type in that it may present sharp edges, is hard to secure in place and is unduly bulky. Such an arrangement has an unprofessional appearance which may be of medical concern to the patient. These types of make-shift devices may not be transparent or may obstruct visualization of the IV site so that the device must be removed to inspect the site.
Because of the problems of patient vena site protection discussed above and a general dissatisfaction with make-shift measures, there are a number of venepuncture shields found in the prior art including the following:
U.S. Pat. No. 3,722,508 shows a combined infusion guard and immobilizer having a portion conforming to a limb such as an elbow, wrist or ankle. Velcro-type hook and eye straps are employed for fastening the immobilizer to a limb or extremity. The infusion guard has an arch extending from one side of the immobilizer to the other side which are connected by complimentary connectors along the length of the immobilizer and guard. The guard includes means for clamping an intravenous tube to the guard and an opening for passing a protecting loop of tubing between the clamp and the intravenous needle.
U.S. Pat. No. 4,919,150 discloses an intravenous catheter shield formed by a base underlying a portion of the patient's limb. A transparent, channel-like housing is hinged to the base and overlies the catheter area in vertical spaced relationship. Velcro-type straps secure the patient's limb to the base and the outer surface of the housing is provided with resilient clamps which grip an IV tube extending across the housing and into the housing interior.
U.S. Pat. No. 4,870,976 shows an injection shield assembly made of rigid transparent plastic material. The assembly includes strap members for holding the assembly to a limb. The assembly when positioned on the limb is longitudinally extending with respect to the limb. A space is defined between the upper most surface of the shield and the limb. Intravenous tubing and a needle can be positioned in this space.
U.S. Pat. No. 4,846,807 shows an IV tube anchor and shield. The device has a continuous frame of resilient foam material strapped to the patient with a central aperture of the frame surrounding the puncture area. A separate dome with ventilation apertures is attachable over the central aperture of the frame to shield the needle. The IV tube is anchored to the frame at a plurality of different locations. The IV tube is threaded through a slot and under tabs in the frame to return bent, or preferably serpentine path and is maintained in position by straps which also secure the frame and dome combination to the body.
While the above devices represent an improvement over the make-shift devices often used for protecting the IV site, these prior art devices have certain disadvantages. Many of the prior art devices, specifically for this purpose, are cumbersome, awkward, and are unnecessarily large and difficult to use. Further, may of the devices are cost prohibitive in today's cost conscious medical industry. The use or incorporation of limb restraints and Velcro-type fasteners adds to the cost and complexity of the devices. Strap-type devices may restrict circulation requiring additional nursing time in circulation checking and documentation. Strap-type devices can act as a tourniquet in the event of IV infiltration and have the additional disadvantage of not being easily useable with injection caps.
Therefore, the principal object of the present invention is to provide a device for shielding and protecting an IV site to minimize the possibility of painful and potentially harmful contact of the IV needle or attached tubing to nearby objects.
Another object of the present invention is to provide a device which is simple, compact and inexpensive to manufacture and which is disposable and is reliable and effective for shielding the IV site.
Another object of the present invention is to provide an IV site protector with a transparent, openable cover for inspection and attendance to the IV site.
Another object of the present invention is to provide an IV site protector having a flexible base which may be placed at various locations and positions on the patient's anatomy and secured by adhesive tape, which tape may be selected to be compatible with the patient such as a hypo-allergenic tape.
Another object of the present invention is to provide an IV protector which is symmetrically configured so it can be conveniently placed in various positions on the patient's body.
Another important object of the present invention is to provide an IV venepuncture protector which may be used to protect a catheter attached to an IV needle or to an unattached IV catheter equipped with an injection cap.
Briefly, the present invention provides a device for protecting and shielding an IV site which device includes a flexible base member fabricated from an elastomeric material. The base member is symmetrical having a plurality of peripherally projecting taping tabs so that the base may be easily secured to the patient at the IV site by use of suitable adhesive medical tape such as Micropore tape. The tabs are optimally located to provide tape securement locations to facilitate placement at various positions on the body of the patient. The opposite ends of the base are formed having openings or recesses permitting IV tubing to pass beneath or through the ends of the device. The tape tabs are configured having retention features to better engage the tape.
A transparent or semi-transparent shield member is secured to the protector base at a living hinge. The base and shield may be integrally formed or the shield may be a thermoplastic material which is secured to the hinge by an appropriate fastener or adhesive member. In the closed position, the shield and base are provided with complimentary locking features which secure the shield in place over the venepuncture site. The nurse or medical attendant may unlock the shield and base, pivoting the shield to an open position for access to the site without disturbing the base. The shield defines oppositely disposed openings so the nurse can open the shield, attach a short-time IV infusion (i.e. antibiotic), close the shield with the attached tubing extending between the cover and base. The base does not have to be removed or disturbed with this procedure.